Systems and methods for monitoring a physiological parameter of persons engaged in physical activity

ABSTRACT

The present disclosure provides system and method for monitoring of at least one physiological parameter of a person engaged in a physical activity, for example, an impact received by a player engaged in a contact sport such as football. The system includes a monitoring unit that actively monitors the physiological parameter of the person, wherein the monitoring unit generates an alert event when the monitored physiological parameter exceeds a threshold of the parameter. The monitoring unit determines whether the parameter exceeds an over-exposure threshold, wherein said threshold is based upon both a single incidence or cumulative incidences.

CLAIM OF PRIORITY UNDER 35 U.S.C. § 119

The present Application for Patent claims priority to ProvisionalApplication No. 61/530,282, entitled “SYSTEMS & METHOD FOR MONITORING APHYSIOLOGICAL PARAMETER OF PERSONS ENGAGED IN PHYSICAL ACTIVITY,” filedSep. 1, 2011, and Provisional Application No. 61/533,038, entitled“SYSTEMS & METHOD FOR MONITORING A PHYSIOLOGICAL PARAMETER OF PERSONSENGAGED IN PHYSICAL ACTIVITY,” filed Sep. 9, 2011, both of which areassigned to the assignee hereof and are hereby expressly incorporated byreference herein.

TECHNICAL FIELD

This disclosure relates to a system and method for monitoring of atleast one physiological parameter of a person engaged in a physicalactivity, for example, an impact received by a player engaged in acontact sport such as football.

BACKGROUND

There is a concern in various contact sports, such as football, lacrosseand hockey, of brain injury due to impact to the head. During suchphysical activity, the head of the individual is often subjected todirect contact which results in impact to the skull and brain of theindividual, as well as movement of the head or body part itself.

Much remains unknown about the response of the brain to headaccelerations in the linear and rotational directions and even lessabout the correspondence between specific impact forces and injury,particularly with respect to injuries caused by repeated exposure toimpact forces of a lower level than those that result in a catastrophicinjury or fatality. Almost all of what is known is derived from animalstudies, studies of cadavers under specific directional and predictableforces (i.e. a head-on collision test), from crash a dummies, from humanvolunteers in well-defined but limited impact exposures or from othersimplistic mechanical models. The conventional application of knownforces and/or measurement of forces applied to animals, cadavers, crashdummies, and human volunteers limit our knowledge of a relationshipbetween forces applied to a living human head and any resultant severebrain injury. These prior studies also have limited value as theytypically relate to research in the automobile safety area.

The concern for sports-related injuries, particularly to the head, ishigher than ever. The Center for Disease Control and Preventionestimates that the incidence of sports-related mild traumatic braininjury (MTBI) approaches 300,000 annually in the United States.Approximately one-third of these injuries occur in football, with MTBIbeing a major source of lost player time. Head injuries accounted for13.3% of all football injuries to boys and 4.4% of all soccer injuriesto both boys and girls in a large study of high school sports injuries.Approximately 62,800 MTBI cases occur annually among high school varsityathletes, with football accounting for about 63% of cases. It has beenreported that concussions in hockey affect 10% of the athletes and makeup 12%-14% of all injuries.

For example, a typical range of 4-6 concussions per year in a footballteam of 90 players (7%), and 6 per year from a hockey team with 28players (21%) is not uncommon. In rugby, concussion can affect as manyas 40% of players on a team each year. Concussions, particularly whenrepeated multiple times, significantly threaten the long-term health ofthe athlete. The health care costs associated with MTBI in sports areestimated to be in the hundreds of millions of dollars annually. TheNational Center for Injury Prevention and Control considerssports-related traumatic brain injury (mild and severe) an importantpublic health problem because of the high incidence of these injuries,the relative youth of those being injured with possible long termdisability, and the danger of cumulative effects from repeat incidences.

Athletes who suffer head impacts during a practice or game situationoften find it difficult to assess the severity of the blow. Physicians,trainers, and coaches utilize standard neurological examinations andcognitive questioning to determine the relative severity of the impactand its effect on the athlete. Return to play decisions can be stronglyinfluenced by parents and coaches who want a talented player back on thefield. Subsequent impacts following an initial concussion (MTBI) may be4-6 times more likely to result in a second, often more severe, braininjury. Significant advances in the diagnosis, categorization, andpost-injury management of concussions have led to the development of theStandardized Assessment of Concussion (SAC), which includes guidelinesfor on-field assessment and return to play criteria. Yet there are noobjective biomechanical measures directly related to the impact used fordiagnostic purposes. Critical clinical decisions are often made on thefield immediately following the impact event, including whether anathlete can continue playing. Data from the actual event would provideadditional objective information to augment psychometric measurescurrently used by the on-site medical practitioner.

Brain injury following impact occurs at the tissue and cellular level,and is both complex and not fully understood. Increased brain tissuestrain, pressure waves, and pressure gradients within the skull havebeen linked with specific brain injury mechanisms. Linear and rotationalhead accelerations are input conditions during an impact. Both directand inertial (i.e. whiplash) loading of the head result in linear androtational head acceleration. Head acceleration induces strain patternsin brain tissue, which may cause injury. There is significantcontroversy regarding what biomechanical information is required topredict the likelihood and severity of MTBI. Direct measurement of braindynamics during impact is extremely difficult in humans.

Head acceleration, on the other hand, can be more readily measured; itsrelationship to severe brain injury has been postulated and tested formore than 50 years. Both linear and rotational acceleration of the headplay an important role in producing diffuse injuries to the brain. Therelative contributions of these accelerations to specific injurymechanisms have not been conclusively established. The numerousmechanisms theorized to result in brain injury have been evaluated incadaveric and animal models, surrogate models, and computer models.Prospective clinical studies combining head impact biomechanics andclinical outcomes have been strongly urged. Validation of the varioushypotheses and models linking tissue and cellular level parameters withMTBI in sports requires field data that directly correlates specifickinematic inputs with post-impact trauma in humans.

In the prior art, conventional devices have employed testing approacheswhich do not relate to devices which can be worn by living human beings,such as the use of dummies. When studying impact with dummies, they aretypically secured to sleds with a known acceleration and impactvelocity. The dummy head then impacts with a target, and theaccelerations experienced by the head are recorded. Impact studies usingcadavers are performed for determining the impact forces and pressureswhich cause skull fractures and catastrophic brain injury.

There is a critical lack of information about what motions and impactforces lead to MTBI in sports.

Most prior art attempts relate to testing in a lab environment. However,the playing field is a more appropriate testing environment foraccumulating data regarding impact to the head. Previous research onfootball helmet impacts in actual game situations yielded helmet impactmagnitudes as high as 530 g's for a duration of 60 msec and greater than1000 g's for unknown durations, both with no known MTBI. Accelerometerswere held firmly to the head via the suspension mechanism in the helmetand with Velcro straps. A recent study found maximum helmetaccelerations of 120 g's and 150 g's in a football player and hockeyplayer, respectively. The disparity in maximum values among theselimited data sets demonstrates the need for additional large-scale datacollection. A limitation of the prior art involves practical applicationand widespread use of measurement technologies that are size and costeffective for individuals and teams. Therefore, there would besignificant advantage to outfitting an entire playing team with arecording system to monitoring impact activities. This would assist inaccumulating data of all impacts to the head, independent of severitylevel, to study the overall profile of head impacts for a given sport.Also, full-time head acceleration monitoring would also be of greatassistance in understanding a particular impact or sequence of impactsto a player's head over time that may have caused an injury and tobetter treat that injury medically.

To address this need, there have been many attempts in the prior art toprovide a system for recording the acceleration and/or impact of anindividual's body part, such as their head. For example, prior artsystems have employed tri-axial accelerometers which are affixed as amodule to the back of a football helmet. Such tri-axial accelerometersprovide acceleration sensing in the X, Y and Z directions which areorthogonal to each other. Tri-axial accelerometer systems require thatthe accelerometers be orthogonal to each other. Also, such tri-axialaccelerometer systems have been extremely expensive making it costprohibitive for widespread commercial installation on an entire team.Prior art systems, have also attempted to precisely locate the variouscombinations of linear and rotational accelerometers, in specificorthogonal arrays, within a helmet to obtain complete three-dimensionalhead kinematics. Such arrays require that the accelerometers bepositioned orthogonal to each other. It is impractical, from a size,cost and complexity standpoint, for commercial application of sucharrays in helmet or head mounted systems.

Obviously, accelerometer arrays for measuring linear and rotationalaccelerations or pressure/force sensors for measuring pressure or forcecannot be readily mounted inside the human head, as is done withinstrumented test dummy heads. Other sensing technologies, such asgyroscopes, magneto hydrodynamic angular rate sensors and GPS sensors,do not currently fulfill the practical and technical specifications fora commercially available system. Also, the use of multi-axisaccelerometer systems placed in a mouth guard are impractical for anumber of reasons, including but not limited to positioning the mouthguard's battery in the user's mouth and the power required to transmitfrom inside the mouth exceeds FCC limits, any of which might present ahazard to the players and limited compliance among them.

In view of the foregoing, there is a demand for a physiologicalmeasuring system for players that can be manufactured and installed atvery low cost to permit widespread utilization. There is a demand for asystem that can be installed in the equipment of many individuals, suchas an entire football team roster of over 60 players, to providereliable monitoring and alerting of different types of impacts receivedby players during the course of play. Further, there is a demand for asystem and method for measuring at least one physiological parameter ofa player that is easy to install and comfortable for the individual towear.

This disclosure solves the problems discussed above and other problemsand provides advantages and aspects not provided by prior art of thistype. A full discussion of the features and advantages of the presentdisclosure is deferred to the following detailed description, whichproceeds with reference to the accompanying drawings.

SUMMARY

The present disclosure provides a system for monitoring of at least onephysiological parameter of multiple players engaged in a contact sport.The system includes a plurality of monitoring units, each monitoringbeing associated with a specific player and having a sensor assemblythat actively monitors at least one physiological parameter of theplayer while engaged in the contact sport to determine a physiologicalparameter value, wherein the monitoring unit selectively generates afirst alert when the physiological parameter value exceeds a firstpredetermined threshold based upon a single incidence of thephysiological parameter and a second alert when the physiologicalparameter value exceeds a second predetermined threshold based uponcumulative incidences of the physiological parameter. The system alsoincludes a portable alert unit that receives the first alert and secondalert transmitted from a particular monitoring unit and displaysinformation relating to the particular alert to a user of the system.

An aspect of the disclosure provides wherein each monitoring unit isconfigured as an in-helmet unit positioned within in a protective helmetworn by a player engaged in the contact sport. Another aspect of thedisclosure provides wherein the sensor assembly comprises a plurality ofsensors formed from an electret film. Yet another aspect of thedisclosure provides wherein the sensor assembly is positioned within anoverliner that is wearable adjacent the player's head while the playeris engaged in the contact sport. A further aspect of the disclosureprovides a protective sports helmet worn by each player engaged in thecontact sport, wherein the sports helmet includes an internal paddingassembly and wherein the overliner is positioned between the player'shead and the internal padding assembly when the sports helmet is worn bythe player. Another aspect of the disclosure provides wherein the sensorassembly is operably connected to a control module, and the sensorassembly further comprises a front sensor positioned adjacent a frontregion of the sports helmet, a rear sensor positioned adjacent a rearregion of the sports helmet, a left sensor positioned adjacent a leftregion of the sports helmet, a right sensor positioned adjacent a rightregion of the sports helmet and a top sensor positioned adjacent a topregion of the sports helmet.

Still another aspect of the disclosure provides a protective sportshelmet worn by each player engaged in the contact sport, wherein thephysiological parameter actively monitored by the sensor assembly is thepressure resulting from an impact to the helmet worn by the playerduring play of the contact sport. Another aspect of the disclosureprovides wherein the first predetermined threshold takes into accountthe player's skill level. A further aspect of the disclosure provideswherein the first predetermined threshold takes into account theplayer's position. Another aspect of the disclosure provides wherein thesecond predetermined threshold includes cumulative impact incidencesoccurring during a prior time interval. Still another aspect of thedisclosure provides wherein an old impact incidence can be removed froma monitoring unit accumulator when they age beyond the prior timeinterval. Another aspect of the disclosure provides wherein a new impactincidence can be added to the monitoring unit accumulator and an oldimpact incidence is removed from the accumulator. A further aspect ofthe disclosure provides wherein the physiological parameter value iscorrelated to a multi-dimensional severity measure and then comparedagainst the first predetermined threshold. Another aspect of thedisclosure provides wherein the multi-dimensional severity measureincludes inputs for linear acceleration and impact direction. Yetanother aspect of the disclosure provides wherein the multi-dimensionalseverity measure includes inputs for the Head Injury Criterion and theGadd Severity Index.

The disclosure also provides for using a weighted principal componentscore such as Head Impact Technology Severity Profile (HIT_(SP)) thattakes into account linear acceleration, Head Injury Criterion (HIC),Gadd Severity Index (GSI), and impact direction.

Other features and advantages of the disclosure will be apparent fromthe following specification taken in conjunction with the followingdrawings. Implementations of the described techniques may includehardware, a method or process, or software for a mobile device on acomputer-accessible medium.

The details of one or more implementations are set forth in theaccompanying drawings and the description below. Other features will beapparent from the description and drawings, and from the claims.

Additional advantages and novel features will be set forth in part inthe description which follows, and in part will become apparent to thoseskilled in the art upon examination of the following and theaccompanying drawings or may be learned by production or operation ofthe examples. The advantages of the present teachings may be realizedand attained by practice or use of various aspects of the methodologies,instrumentalities and combinations set forth in the detailed examplesdiscussed below.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawing figures depict one or more implementations in accord withthe present teachings, by way of example only, not by way of limitation.In the figures, like reference numerals refer to the same or similarelements.

FIG. 1A illustrates an exemplary system in which a player helmetactively monitors physiological parameters of a player and generatesalert events when the monitored physiological parameters exceed athreshold.

FIGS. 1B-1C illustrate different views of player helmet shown in FIG.1A.

FIG. 2 illustrates an exemplary IHU that fits within the player helmetshown in FIG. 1A.

FIG. 3 illustrates a schematic of the IHU shown in FIG. 2.

FIG. 4 illustrates an exemplary table displaying HITsp exposurethresholds for a lower skill level of players.

FIG. 5 illustrates an exemplary table displaying HITsp exposurethresholds for a higher skill level players.

FIG. 6 illustrates an exemplary flow for creation of time-weightedcumulative severity metric.

FIGS. 7A-7C illustrate an exemplary control module shown in FIG. 2.

FIGS. 8A-8I illustrate an exemplary process for starting the PMS andassigning a player helmet to a specific alert unit shown in FIG. 1A.

FIG. 9 illustrates an exemplary UI allowing the user to download alerts.

FIG. 10 illustrates an exemplary UI allowing the user to modify systemsettings.

FIG. 11 illustrates an exemplary alert unit.

FIG. 12 illustrates a network or host computer platform, as maytypically be used to implement a server.

FIG. 13 illustrates a computer with user interface elements, as may beused to implement a personal computer.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are setforth by way of examples in order to provide a thorough understanding ofthe relevant teachings. However, it should be apparent to those skilledin the art that the present teachings may be practiced without suchdetails. In other instances, well known methods, procedures, components,and/or circuitry have been described at a relatively high-level, withoutdetail, in order to avoid unnecessarily obscuring aspects of the presentteachings.

It should be understood that the present disclosure relates generally toa system for actively monitoring at least one physiological parameter ofplayers engaged in a sports activity, such as pressure or force on abody part (e.g., the head) and/or the acceleration of a body part (e.g.,linear acceleration or rotational acceleration), both resulting from animpact or series of impacts to the player(s). The present disclosure, aswill be discussed in detail below, is capable of monitoring any bodypart of an individual but has particular application in monitoring thehuman head. Therefore, any reference to a body part is understood toencompass the head and any reference to the head alone is intended toinclude applicability to any body part. For ease of discussion andillustration, discussion of the prior art and the present disclosure isdirected to the head of human, by way of example and is not intended tolimit the scope of discussion to the human head.

FIG. 1A illustrates an exemplary system 1100 in which a player helmet1110 actively monitors at least one physiological parameter of a playerand generates alert events when the monitored physiological parameter(s)exceed a threshold. Since most contact sports involve multi-playerteams, the system 1100 simultaneously measures, records and transmitsthe data on the selected physiological parameter for all players on theteam throughout the course of play, including a game or practice. System1100 is especially well suited for helmeted team sports where playersare susceptible to head impacts and injuries; for example, football,hockey, and lacrosse. The system 1100 could also be employed protectiveequipment other than helmets (e.g., shoulder pads or knee pads), or insports where helmets are not traditionally worn; for example, rugby orsoccer. The system 1100 could also be employed in military helmets, bikeand motor sports, and winter sports (e.g. downhill skiing and skijumping).

In one specific example, the system 1100 is configured to assess whethera particular impact or series of impacts received by a player exceedstwo, weighted over-exposure thresholds based upon a single impact and/orcumulative impacts over a predefined amount of time (e.g., 7 days).These over-exposure thresholds are determined from the results ofmonitoring over 1,300 players using a system described in U.S. patentapplication Ser. Nos. 10/997,832; 11/225,880; and 11/328,445, whereinmore than +1.4 million head impacts have been recorded to date andstored within a database. Using this database and proprietaryalgorithms, two types of over-exposure thresholds have beencreated—single event threshold and cumulative threshold.

When configured for helmeted team sports, such as football, the system1100 includes at least player helmet 1110, an alert unit 1120, and auser terminal 1130 (see FIG. 1A). The player helmet 1110, includes anin-helmet unit (or monitoring unit) 1200 that is configured to monitorand analyze both single and cumulative impacts to the player wearing theplayer helmet 1110 (see FIG. 1B). The impact data may be correlated to amulti dimensional severity measure (e.g., weighted principal componentscore such as Head Impact Technology Severity Profile (HIT_(SP)) thattakes into account linear acceleration, Head Injury Criterion (HIC),Gadd Severity Index (GSI), and impact direction. The impact severity mayalso be weighted by impact location.

In one embodiment, the in-helmet unit (or monitoring unit) 1200 measuresa physiological parameter, such as pressure resulting from the helmetimpact, and weighs this value by impact location to determine theseverity level of the received impact and then compares it against theHITsp threshold programmed inside the in-helmet unit (or monitoringunit) 1200. In another embodiment, the in-helmet unit 1200 measuresmultiple physiological parameters, such as the impact pressure andacceleration (such as linear and/or rotational acceleration) resultingfrom the impact(s). The in-helmet unit 1200 may also measure differentmodalities, for example, both piezo and electret film within thein-helmet unit 1200 can measure changes in temperature and othermechanical stress due to sound and/or air pressure. This provides theability to measure simultaneous effects using a single sensor, such asan impact to a player and the player's temperature, for example. Impactdata is continually monitored for a value from any channel 1220 a-e thatexceeds a predetermined threshold programmed into the in-helmet unit1200. Once triggered, a microcontroller wakes up and collects data fromall channels 1220 a-e. Impact data may be stored in an analog domain inthe in-helmet unit 1200 using peak hold circuits, and peak hold valuesmay be collected from each channel 1220 a-e. If any channel data exceedsthe predefined threshold, that data is processed further to determine acalculated value. If the calculated value exceeds the predefined singleimpact alert threshold, then the alert, namely the single impact alert,is sent. If the calculated value is not peak magnitude alertable (i.e.,it is below the alert threshold), then the calculated value is evaluatedto determine if it should be added to the cumulative calculation. If thecalculated value is added to the cumulative calculation, the processedcumulative value is compared to the predetermined cumulative impactalert threshold. If the processed cumulative value exceeds that alertthreshold, then a cumulative alert (or multiple impact alert) is sent tothe remote alert unit 1120. The system 1100 may be configured such thatonly one cumulative alert for a particular player can be sent per day.The system 1100 may also be configured to include the player's medicalhistory and/or injury history as part of the impact monitoring,threshold calculation and/or alert criteria. For example, if a specificplayer has a known medical condition, then the system 1100 may take thatcondition into account when performing the threshold calculation and/orsending an alert to the remote unit 1120. Also, the remote unit 1120 maybe configured to also display that player's medical condition whendisplaying the single impact alert and/or the cumulative impact alert.

As an example regarding the single event, peak overexposure may bedetermined in which each individual peak channel recorded is scaled to acalibration value determined at the time of manufacturing. Subsequently,each individual channel is transformed into a HITsp value based on theindividual channel location using a 3^(rd) order polynomial. Finally theHITsp values from the peak individual channel along with physicallyadjacent channels are summed together to provide a final HITsp severitymeasure. For example, if the peak channel (i.e. highest magnitude) isthe left channel, adjacent values from the top, front, and back areincluded in the final HITsp severity measure. As an example regarding acumulative event, cumulative exposure may be determined in which onlydata that are above a 95% threshold for an individual's playing positionand skill level are included in the calculation of cumulative exposure.This threshold may be based on a proprietary database consisting ofmillions of impacts from thousands of players. With each impact that isadded to a monitoring unit accumulator or database cumulative bucket,the monitoring unit accumulator or cumulative bucket magnitude decreasesbased on an exponential decay function. This final cumulative value iscompared to an alerting threshold based on playing position and skilllevel.

Using these over-exposure thresholds, system 1100 can identify when aplayer has sustained a single impact or series of impacts that areatypical for their skill level and/or playing position. Thus, singleimpacts and/or multiple impacts can be weighted based upon the player's(wearer's) skill level, playing level or both. The skill level can bedivided into lower levels and upper levels. The lower levels include,for example, youth and high school players. The upper levels include,for example college and professional players. The playing positions canbe defined by well-recognized positions, including offensive line,running backs, quarterback, wide receivers, defensive linemen,linebackers, defensive backs and special teams. The playing positionscould also be defined by the player's attributes, including neck size,age, head size, weight, and body mass index. Over-exposure alerts givesideline staff members an indication that an abnormal physiologicalparameter result (e.g., head contact has occurred and the potential forinjury may exist). When the system 1110 is configured to monitor headimpacts, this allows team staff to identify players who are prone toatypical head contact and/or styles of play that lead to over-exposure.Essentially, system 1100 acts as an on-field set of eyes that cancontinually monitor players where the sideline personnel, includingcoaches and trainers can not.

The system 1100 is configured to monitor impacts, determine the severitylevel of a received single impact or cumulative impacts and then makes acomparison of that severity level against a threshold value of acomparative metric to provide a “single impact alert” and/or a“cumulative impact alert.” The comparator employed by the system 1100can be linear acceleration, a combination of linear acceleration andother measured values, or a combination of accelerations, values andconstants. Preferably, the system 1100 utilizes “HITsp” as thecomparator, wherein HITsp is a composite variable that combines measuresof linear acceleration, rotational acceleration, and impact durationinto a single metric that is then weighted by impact location. While notdiagnostic of injury, HITsp has been shown to be more sensitive andspecific to diagnosed concussion than any of the component measuresalone. Specifically, HITsp has been shown to be 50% more sensitive topredict a subsequently diagnosed concussion than usage of any individualmeasure by itself (e.g., linear acceleration). The published paper,titled HEAD IMPACT SEVERITY MEASURES FOR EVALUATING MILD TRAUMATIC BRIANINJURY RISK EXPOSURE, the entire content of which is incorporated hereinby reference, describes this method in greater detail and is attached asAppendix A. In the following description, the system 1110 utilizes theHITsp as the comparator for threshold analysis. However, as noted above,other thresholds or combination of thresholds may be used. When acalculated parameter result approaches or exceeds a predetermined levelor threshold determined by HITsp, the system 1100 notifies the qualifiedsideline personnel and utilize the method of the present disclosure toevaluate and treat the player(s) in question. At the proposedthresholds, HITsp is more sensitive to a diagnosed concussion thanmonitoring linear acceleration.

As discussed below, the in-helmet unit 1200 comprises a novel sensorassembly 1220 and control module 1230 (see FIGS. 1B, 1C and 2). Thesystem 1100 can be configured for use with a protective shoulder padassembly worn by a player engaged in the contact sport, wherein themonitoring unit 1200 is incorporated in the shoulder pad structure,including the protective arches that overlap the player's shoulder,chest and back regions. In a preferred embodiment, the rotationalacceleration component of an impact is not measured by the sensorassembly 1220, however, the rotational acceleration component isincluded in the HITsp comparator. An alert event occurs if the in-helmetunit 1200 determines that the severity level of the received impactexceeds the HITsp threshold for a single impact and/or cumulativeimpacts. The in-helmet unit 1200 generates an alert and communicates thealert to the alert unit 1120 through the communication link 1140. Anover exposure condition is defined as either sustaining a single impactseverity in the predetermined threshold percentile (e.g., 99 percentile)for that skill level and player position, or exceeding cumulativeimpacts severity calculated over a predefined period of time (e.g., 7days) for that player skill level and player position, as described inmore detail below. Thus, the in-helmet unit 1200 provides an alert tothe alert unit 1120 based upon an evaluation of single impact andcumulative impacts, weighted in light of the player's skill level andthe player's position.

The alert unit 1120 receives the alert and displays it to the sidelinepersonnel bearing the alert unit 1120. For each alert, the alert unit1120 displays the affected player's identity, for example by name orjersey number, the measured parameter, and the time of the alert event.However, the player's identity can be protected by use of a uniqueplayer identifier, which may be encoded and/or encrypted. For example,encoding the signals or data with a unique identifier enables the system1100, namely the alert unit 1120, to properly decode and/or multiplexinformation from the various in-helmet units 1200 simultaneouslytransmitting alerts and/or data. As another example, the parameter datamay be encrypted to increase the security of the underlying data, suchas by using a cipher for performing encryption and decryption, and a keyto parameterize the cipher. The time stamp of the alert event allowssideline personnel and medical staff to correlate the calculatedparameter to actual videotape of the sporting event that led to thealert event. Once an alert event has occurred, the in-helmet unit 1200can send a signal to the alert unit 1120 that alerts the sidelinepersonnel to employ a method for evaluating and treating the player inquestion, as explained below. The player in question is quicklyidentified by the in-helmet unit 1200 due to the unique identifierprovided by the in-helmet unit 1200 and the subsequent recognition ofthe identifier and the multiplexing performed by the alert unit 1120. Inthis manner, the sideline personnel including those bearing the alertunit 1120 can efficiently evaluate the player in question from among themany players comprising the team. The alert unit 1120 can take the formof portable handsets, smart-phones or personal digital assistants,although they may be implemented in other form factors. Programapplications, including an application for evaluating and treatingplayers based upon the results of alerts communicated to the alert unit1120 can be configured to execute on many different types of alert unit1120.

The system 1100 also includes a user terminal 1130, such as a customuser device, a laptop, a tablet computer or a smartphone, for example.The user terminal 1130 may be programmed with Player Management Software(PMS) that allows various components of system 1100 to communicate andinteract and that provides the coach all information necessary foroperating system 1100. The user terminal 1130 may connect to the alertunit 1120 via a wired or a wireless connection. In one example, thealert unit 1120 connects to the user terminal 1130 via a USB connection.In interacting with the PMS, user informs the software that the userswishes to add a new player helmet 1110 to a list of player helmets 1110monitored by the alert unit 1120. As a result, PMS launches a wizardthat advises the user to place the in-helmet unit 1200 into aconfiguration state by holding down the button on the control module1230 for prolonged period of time (e.g., 5 seconds). A fast flashingyellow LED on the control module 1230 confirms this state. The in-helmetunit 1200 remains in this state for 30 seconds. The user then clicks the“next” button in PMS that begins configuration setup on the in-helmetunit 1200 through the alert unit 1120 acting as a modem. Configurationsetup may include obtaining the unique serial number of the in-helmetunit 1200 and storing it in a database for later association with aspecific player. The configuration setup also may include assigning anappropriate RF parameter for enabling communication between thein-helmet unit 1200 and the alert unit 1120. The database may be locatedat the alert unit 1120 or may be located remote from the alert unit butaccessible to the alert unit 1120 via wired or a wireless connection.For example, the database may correspond to the database 1150. The PMSconfirms successful configuration.

In one example, the communication link 1140 is wireless utilizing RFcommunication protocol based on time division multiplexing approach. Inapproximately every 9.6 seconds, the alert unit 1120 broadcasts a ping75 times every 30 ms. After each ping, the alert unit 1120 listens foran in-helmet unit 1200 that is scheduled to respond at a specific pingset and time slot. There are two time slots per ping where an in-helmetunit 1200 can respond. The ping plus time slot listen period is a“superframe.” At setup, the PMS configures the in-helmet unit 1200 withthe appropriate RF info (e.g. channel, PAN ID, etc) as well as atimeslot within a superframe. Since communications are happeningasynchronously and the actual communication time is in a small window,the in-helmet unit 1200 wakes up periodically at some multiple of pingwindows (the 75 superframes). If it hears a ping from it's alertmonitor, the in-helmet unit 1200 calculates the time required to wakeupon the next ping cycle (9.6 sec + an offset it calculates to wakeupright before the appropriate superframe). After an in-helmet unit 1200checks in with the alert unit 1120, the alert unit 1120 responds with anacknowledgment. Included in this acknowledgment is the player thresholdinformation. The alert unit 1120 updates threshold information from thePMS when the user syncs. Upon the next communication with the in-helmetunit 1200, the alert unit 1120 communicates this information to thealert unit 1120. The in-helmet unit 1200 monitors the impacts to theplayer wearing the in-helmet unit 1200 and reports an alert to the alertunit 1120 if the impacts exceed the threshold of the comparator, onsingle impact basis or cumulative impact basis.

FIG. 1B illustrates an enlarged view of the player helmet 1110. FIG. 1Cillustrates an interior of the player helmet 1110. As shown, playerhelmet 1110 includes the face guard 1110 a, primary internal paddingassembly 1110 b, and an overliner 1110 c. The overliner 1110 c isconfigured to include the in-helmet unit (IHU) 1200, a secondary paddingassembly 1210 (which preferably has a thinner configuration than theprimary internal pad assembly 1110 b). Alternatively, the secondarypadding assembly 1210 is omitted from the overliner 1110 c. In FIG. 2,the in-helmet unit 1200 includes a sensor assembly 1220 and a controlmodule 1230 connected to the sensor assembly 1220 via a connector 1232.The sensor assembly 1220 includes five sensors 1220 a, 1220 b, 1220 c,1220 d, and 1220 e that each provide distinct electrical channels. Asshown, sensors 1220 c and 1220 d each have a horizontal component 1220 c1, 1220 d 1, and a vertical component 1220 c 2, 1220 d 2. The in-helmetunit 1200 is fitted within the overliner 1110 c and when the overliner1110 c is positioned within the player helmet 1110, the overliner 1110 crests on the players head. Accordingly, the sensor assembly 1220 isbetween the secondary pad assembly 1210 and the primary internal padassembly 1110 b. To this end, the sensor assembly 1220 does not directlytouch the player's head. In a slightly different implementation, thesensor assembly 1220 is fitted on the front side (or interior portion)of the overliner 1110 c such that when the overliner 1110 c ispositioned within the player helmet 1100, the sensor assembly 1220 isadjacent to the player's head. In yet another implementation, theoverliner 1110 c is omitted and the sensor assembly 1220 is integratedwith the primary internal pad assembly 1110 b, wherein the sensorassembly 1220 is positioned within the housing members that form theinternal pad assembly 1110 b. Alternatively, the sensor assembly 1220 isintegrally formed as part of the housing that comprises the internal padassembly 1110 b.

In one implementation, the sensors 1220 a-1220 e of the sensor assembly1220 are formed from an electret film, which has a unique, strongelectromechanical response to an impact(s) to the helmet 1110. The filmis based on a polyolefin material manufactured in a continuous biaxialorientation process that stretches the film in two perpendiculardirections (machine direction and the transverse direction). Further thefilm is expanded in thickness at high-pressure gas-diffusion-expansion(GDE) process. The structure of electret film consists of flat voidsseparated by thin polyolefin layers. Typically the electret film is70-80 μm thick. The voids are made by compounding small particles, whichfunction as rupture nuclei and form closed lens like cavities to thefilm during the biaxial orientation. The voids are enlarged at with theGDE process, which more than doubles the thickness and elasticity of thefilm by increasing the size of air-voids inside it. Electromechanicalresponse with GDE processed film is over 10-fold compared to non-swelledfilm. A permanent electric charge is injected into the material bycorona charging it in high electric field. This causes electricbreakdowns occur inside the material, thus charging the void interfacesinside the film in order to form an electret material capable ofinteracting with its environment. Thin metal electrodes are, forexample, arranged by screen-printing them first to 75-100 μm polyesterfilm and laminating together with electret film. Vacuum evaporation toboth surfaces of the film is also possible for actuator purposes. Othertypical ways to arrange electrodes is using aluminum-polyester laminateand etching the electrode pattern prior laminating with electret film.In another implementation, the sensors 1220 a-1220 e are made ofpiezoelectric material. Two very distinct forms of piezoelectricmaterials were evaluated and characterized during impact: PolyvinylideneFlouride (PVDF) and Lead Ziconate Titanate (PZT). PZTs are ceramic discswith a high piezoelectric constant, but are extremely fragile. Incontrast, PVDF is a polmner that exhibits piezoelectric effects and canbe silkscreened onto flexible substrates (e.g., Mylar®) in an ultrathincoating creating a flexible sensor and vastly improved durability.

Although the in-helmet unit 1200 is shown and described to include fivesensors 1220 a-e, one of ordinary skill in art recognizes that thein-helmet unit 1200 may have more or less sensors. The number of sensorsmay depend on the application and the information that is required tomeet the needs of the application. For monitoring at least onephysiological parameter of player engaged in a sports activity, forexample a football player, the impact location as part of impactseverity calculation is important. Therefore, the in-helmet unit 1200includes five distinct sensors 1220 a-e for five distinct regions (e.g.,top, left, right, front, and back) of the helmet 1100, which alsocorresponds to the player's head regions. Each sensor 1220 provides anelectrical channel for helmet impact data acquisition and processing.For off-center impacts (as opposed to on-center impacts), the system1100 includes algorithms that can evaluate the ratio of impact energyrecorded by adjacent channels to estimate to a higher resolution(approximately 10 degrees). When an impact to the helmet 1110 isdetected by multiple sensors, only data from the closest sensor to theimpact location and the sensors adjacent to the closest sensor is usedin the weighting calculation. For example, when an off-center impact isreceived on the helmet 1100 and the back sensor 1220 e and left sensor1220 c detected equal impact energy without significant energy fromother sensors, then the impact location is determined by the system 1100to be directly between the back sensor 1220 e and left sensor 1220 c.Also, if the impact location is on the left side of the helmet 1110, thesystem 1100 will combine usable data from the left 1220 c, front 1220 a,top 1220 b, and rear 1220 c sensors for the weighting calculation, butany data recorded by the right 1220 d sensor will be ignored. Similarly,when an on-center impact is applied to the front of the helmet 1110, anydata from the rear sensor 1220 e is ignored. Accordingly, the system1110 is configured to selectively utilize data from a limited number ofthe sensors 1220 a-e while disregarding other, essentially irrelevantsensor data, based upon the location of the impact to the helmet 1110.

The system 1100 is also configured to monitor impacts and process datafrom players who experience multiple impacts on the same play. A personof skill in the art of designing sophisticated monitoring equipment forcontact sports recognizes that many football players, including runningbacks, offensive lineman and defensive lineman, experience multipleimpacts on a single play. For example, when a running back receivesmultiple impacts while carrying the football (e.g., a rushing play),every impact detected by the sensors 1220 is compared to the HITspthresholds, as long as a specified time (e.g., 60 ms) has passed betweenimpacts. In the context of the running back receiving two impacts, ifboth detected impacts exceed the single event impact threshold, eachimpact is treated as an independent peak overexposure alert and thealert unit 1120 provides the alert described above. For each alertableevent, the alert unit 1120 provides the alert relevant information,including the type of alert, the time of alert (down to milliseconds),and the unique player identifier that sustained the impacts in question.It is contemplated that any other type of relative information may beincluded in the alert that is sent, such as impact or temperature date,for example.

In another application, where impact location is not necessary, a singlesensor may be used. A single sensor in this context would still havesufficient material to mostly cover the surface of the head, but wouldelectrically appear as one channel. The sensor assembly 1220automatically and continuously measures and records the player'sphysiological parameters and transmits data regarding the parameter tothe control module 1130. The control module 1230 is operably connectedto each of sensors 1220 a-1220 e via a separate wire lead or channel.

FIG. 3 illustrates a schematic of the IHU 1200. As shown, the controlmodule 1230 is connected via a separate wire lead 1226 to each ofsensors 1220 a-1220 e. The control module 1230 includes a signalconditioner 24 a, a filter 24 b, a microcontroller 24 c (ormicroprocessor), a telemetry element 24 d, an encoder 24 e, and a powersource 24 f. The control module 1230 includes a shake sensor 24 g thatmay be used to turn the in-helmet unit 1200 ON or OFF based on aspecific shake pattern of the player helmet 1110. For example, hittingand/or shaking the player helmet 1110 once may turn it ON; whereas,hitting and/or shaking the player helmet 1110 twice may turn it OFF orvice versa. Alternatively, the player helmet 1110 may have controlbuttons, such as a power button and a configuration button, for example.The in-helmet unit 1200 has low power requirements, providing for longbattery life, thereby optimizing the continued use of the in-helmet unit1200. For example, in normal operation (e.g., continuous monitoring foralertable impacts), the in-helmet unit 1200 may consume about 12-20 uA.In a deep sleep state (e.g., everything is off except time keeping), thein-helmet unit 1200 may consume about 8 uA. In an alert state (e.g., thein-helmet unit 1200 is trying to send an alert to the alert unit 1120)the in-helmet unit 1200 may consume about 1-5 mA.

As mentioned above, the control module 1230 is configured to performvarious impact calculations and send an alert to an alert unit 1120 whena predetermined threshold is exceeded. The control module 1230 enablescontinued monitoring and analysis of head impacts on two basis: singleimpact and cumulative impacts. Both single impact analysis andcumulative impact analysis may take into account player's position(e.g., quarterback, linebacker, and running back in football, forexample) and player's skill/playing level (e.g., elementary, highschool, college or professional). The control module 1230 sends an alertto the alert unit 1120 for all impacts exceeding single impactover-exposure threshold. The single impact over-exposure threshold maybe at the level that is inclusive of diagnosed concussion. Additionally,the single impact over-exposure threshold may be at the level that aretypically experienced during play (e.g., warning that excessive exposurehas occurred). To this end, the single impact over-exposure thresholdmay be set at the 99th percentile of impact exposure for two weightingfactors: skill level (youth, high school, NCAA, Pro) and position (DB,DL, LB, OL, QB, RB, ST, WR). The 99th percentile of impact exposure maybe obtained from teams associated with different skill level.

As another example, to measure the player's temperature, each in-helmetunit 1200 includes at least one temperature measuring sensor such as athermistor, which comprises resistive circuit components having a highnegative temperature coefficient of resistance so that the resistancedecreases as the temperature increases. Alternatively, the temperaturesensor is a thermal ribbon sensor or a band-gap type integrated circuitsensor. To measure both the acceleration and temperature of the player'sbody part, the sensors can be a combination of accelerometers andthermistors operably connected to the control module 1230. Where thesystem 1100 is configured for use with a football team to measure andmonitor head acceleration and player body temperature, the sensors areaccelerometers and thermistors that are arrayed in an in-helmet unit1200 for each player. To measure other physiological parameters, such asthe player's heart rate and blood pressure, the sensors are microelectromechanical system (MEMS) type sensors that use auscultatory(e.g., listening to the internal sounds made by the body) and/oroscillometric (e.g., oscillations of the arterial pulse) measurementtechniques. In another embodiment, the sensors may include lowacceleration (low G) accelerometers that are configured to measure smallmovements of the player's head consistent with balance problems. Thesystem 1100 includes an algorithm that calculates and observes aplayer's balance between plays or during extended stoppages in play,such as when a penalty is being assessed or a timeout. In this manner,the player's physiological parameter can be measured on the field ofplay, instead of the sideline. When a player assumes the ready positionprior to the commencement of the play, for example a three-point stance,the low G accelerometers and the algorithm would detect player movementsindicative of balance problems and a concussion.

In an embodiment where the system 1100 monitors each player's bodytemperature, the alert unit 1120 receives data from the in-helmet units1200 and then calculates each player's body surface temperature, therate of temperature increase and/or decrease versus a selected timeinterval. In addition to the temperature sensor, the system 1100 caninclude an additional temperature and/or humidity sensor to measureambient conditions and use the resulting data for correction purposes.When the system 1100 is configured for player body temperaturemonitoring in helmeted team sports, the in-helmet unit 1200 can bepositioned within the helmet 1100 or within other protective equipmentworn by each player, such as a shoulder pad assembly. The alert unit1120 receives the temperature data from each in-helmet unit 1200 andthen applies an algorithm to calculate the player's body surfacetemperature, the rate of temperature increase and/or decrease, and othertemperature-based parameters that aid in the evaluation of playerthermal management.

FIG. 4 provides a table 1400 displaying the HITsp exposure thresholdsfor a lower level skill level of players (e.g., high school players) forvarious player positions (e.g., defensive backs (DB), defensive line(DL) and linebacker (LB)). The number of lower level players for each ofthe three positions is provided, as well as the total number of impactsfor each player position. Data from additional players in differentpositions (offensive line, quarterback, running back, wide receiver, andspecial teams) was obtained but is not included in FIG. 4. The data intable 1400 was collected from players among 12 teams using the systemsand methods described in U.S. patent application Ser. Nos. 10/997,832;11/225,880; and 11/328,445. The table 1400 includes players row 1410,impacts row 1412, and the HITsp exposure threshold row 1416 for specificplayer positions, wherein the threshold T1-T3 can be set by the systemoperator (e.g., the 99th percentile) and subsequently adjusted.Applicants have determined that the HITsp exposure threshold T1-T3varies with player position, i.e., among defensive backs, defensivelinemen and linebackers.

FIG. 5 provides a table 1500 displaying the HITsp exposure thresholdsfor a higher skill level of players (e.g., college and/or professionalplayers) for defensive backs (DB), defensive line (DL) and linebacker(LB) player positions. The number of upper level players for each of thethree positions is provided, as well as the total number of impacts foreach player position. Data from additional players in differentpositions (offensive line, quarterback, running back, wide receiver, andspecial teams) was obtained but is not included in FIG. 5. The exemplarytable 1500 was collected from the prior monitoring of numerous footballteams. The table 1500 includes players row 1510, impacts row 1512, andthe HITsp exposure threshold row 1516, wherein the threshold T4-T6 canbe set by the system operator (e.g., the 99th percentile) andsubsequently adjusted. Applicants have determined that the HITspexposure threshold T4-T6 varies with player position, i.e., amongdefensive backs, defensive linemen and linebackers. Applicants have alsodetermined that between the player positions, the HITsp exposurethresholds for the higher skill level players exceed the thresholds forthe lower level skill players.

The control module 1230 sends an alert to the alert unit 1120 when acumulative impact to the player over the defined period of time exceedsthe multiple impact over-exposure threshold, even if none of theindividual impact exceeds the single impact threshold. The cumulativeimpacts correspond to multiple impacts over a defined period of time.The defined period of time corresponds to seven days in one specificexample. The accumulation process may assign a “weight” to olderimpacts. The accumulation process also allows for removal of olderimpacts that are beyond the time period to allow for newer impacts to beadded. Applicants have determined that alerts based upon cumulativeover-exposure increases sensitivity of the system 1100 to diagnosedconcussion by a considerable amount.

FIG. 6 illustrates an exemplary flow 1700 for creation of time-weightedcumulative severity metric. As shown, if the impact is greater than 95percentile for the given skill level and position, the impact isrecorded in a database (e.g., shown as a bucket for illustrativepurposes). Overtime, the impact is subjected to time “weighted” decay toreduce the level of impact. For example, the impact that recorded 4 daysago may be multiplied by 0.4 weighting factor, thereby reducing thelevel of impact. Once the cumulative impact recorded in the databaseexceeds the multiple impact over-exposure threshold, the alert isgenerated and sent to the alert unit 1120. The cumulative impactincreases sensitivity for “delayed diagnosis” concussion, which aretypically associated with lower peak severity. In one example, “delayeddiagnosis” concussions means concussions that were not directlydiagnosed following an observed impact and instead were diagnosed laterin the day or the next day. Impact associated with the “delayeddiagnosis” is the maximum severity impact of the day. One skilled in theart recognizes that weighting variables (e.g., time window, decayfunction, input threshold) are adjustable. The control module 1230 maybe housed inside translucent housing.

FIGS. 7A-7C illustrate an exemplary control module 1230. FIG. 7Aillustrates a perspective view of the control module 1230 having ahousing 1234 and a connector 1232. FIG. 7B illustrates a front view ofthe control module 1230 with LED indicators 1236 to show operational orconnectivity status, such as successful pairing of the control module1230 with its corresponding alert unit 1120. FIG. 7C is a rear view ofthe control module 1230 with the rear portion of the housing 1234removed. A battery 1238 provides power to the control module 1230 andmay be a standard sized battery, thereby allowing for cost effective andsimple replacement.

The control module 1230 may send an alert to the alert unit 1120 for allimpacts exceeding single impact over-exposure threshold. Similarly, thecontrol module 130 may send an alert to the alert unit 1120 when acumulative impacts to the player over the defined period of time exceedthe multiple impact over-exposure threshold even if none of theindividual impact exceeds the single impact threshold.

To support simultaneous transmissions from multiple control modules1230, the signals sent from each control module 1230 can be divided withany suitable division process, such as time division multiple access(TDMA), code division multiple access (CDMA), or frequency divisionmultiple access (FDMA) technology, for example. As a TDMA example, up tofour teams may be assigned to any one computer at an institution. Eachteam may communicate with up to 150 players simultaneously. A team mayhave up to two alert monitors per team or eight alert monitors in totalassigned to the computer. A team may be defined as freshman, juniorvarsity (JV), varsity or varsity offense, varsity defense, for example.Users may define whatever construct they want. Players assigned to teamsare not heard or seen by alert monitors from a different team. Each teamis assigned a different operating channel based on the 802.15.4 standardoperating within the 2.4 Ghz band. Two alert monitors per team mayco-exist and may simultaneously receive alerts from players. Forexample, it takes approximately 2.4 seconds for an alert monitor to scanfor 150 player units. To accommodate simultaneous receipt of an alert,alert monitors initially wake up listening for other alert monitors inclose vicinity. If the newly woken alert monitor hears another alertmonitor in close vicinity, the newly woken alert monitor is able todetermine the next available scan period. If an alert monitor scansevery 9.6 seconds for about 2.4 seconds, this allows up to four alertmonitors to co-exist in a TDMA scenario. For example, this leaves twoalert monitors per team (e.g. visitor and home) to co-exist.

FIGS. 8A-8I illustrate an exemplary process for starting the PMS andassigning a in-helmet unit 1200 to a specific alert unit 1120. FIG. 8Aillustrates an exemplary User Interface (UI) 2000A that is demonstratedto the user upon activation of the PMS. The PMS may be activated byselection of its respective icon on the user terminal 1130.

FIG. 8B illustrates an exemplary UI 2000B informing the user that PMS issearching for a new alert unit 1120. The UI 2000B requests the user toconnect an alert unit 1120 to the user terminal 1130. The alert unit1120 may be connected to the user terminal 1130 via a USB connection.When the user connects the alert unit 1120 to the user terminal 1130,PMS automatically brings up the “Adding a New Alert Unit” Wizard.

FIG. 8C illustrates an exemplary UI 2000C informing the user that thealert unit 1120 has been detected. The UI 2000C also requests that theuser name the alert unit 1120 for easy alert monitoring management andclicks next. To this end, if the user has more than one alert unit 1120,the user may disconnect the alert unit 1120 and connect the second alertunit 1120 and repeater this process until the user has added all newalert units 1120 and named them. Then, the user can move on toconfiguring the player helmets 1110.

Once the user completed the alert unit 1120 wizard, the user canconfigure the in-helmet unit 1200 using the player helmet wizard. First,the user has to make sure that the control module 1230 is connected tothe sensor assembly 1220 of the IHU 1200 inside the helmet overliner(overliner can be in or outside of the helmet). Upon connecting thecontrol module 1230 with the sensor assembly 1220, the user should see ared light blink 3 times to indicate the power is connected. Then, theuser should ensure that the user terminal 1130 is connected to one ofthe alert units 1120 and alert unit wizard is completed. Once the alertunit wizard is completed, the player helmet wizard appears on the user'sPC display. The player helmet wizard may also appear when the userconfigures new in-helmet unit 1200 while working with the PMS.

The player helmet wizard displays “equipment assignments” tab selectionof which allows the user to add a player helmet. If the user wishes toadd more player helmets the user may select a “+” button within the“equipment assignments” window. To synchronize the player helmet thathave been assigned to a specific alert unit 1120, the player helmetwizard instructs the user to press the round “Sync” button on thein-helmet unit 1200 until the orange light starts blinking quickly. FIG.8D illustrates an exemplary UI 2000D instructing the user to hold the“Sync” button on the in-helmet unit 1200 for five seconds to enable thein-helmet unit 1200 to be associated with the alert unit 1120 connectedto the user terminal 1130.

FIG. 8E illustrates an exemplary UI 2000E allowing the user to assign anew player to the added in-helmet unit 1200. To add a new player, the UI2000E instructs the user to “Player Set-up” tab and select “Player List”tab within a window generated as a result of selection of “PlayerSet-up” tab. The user may select the “+” button at the bottom of thewindow to insert a player into the list of players. From there, the usercan name the player's jersey number, which may be used for alertidentification. Additionally, the user may select the drop down box inthis window to select the player's position, assign a in-helmet unit1200 to the player from among the various in-helmet units 1200 that havebeen added to PMS. To this end, in-helmet units 1200 that have beenadded to the system will automatically appear on the drop down list.Additionally, the user may select the drop down box to identify theplayer's playing level. After identification of these criteria for theplayer, the user can save the changes and can click “+” button add moreplayers to the system.

FIG. 8F illustrates an exemplary UI 2000F allowing the user to create aroster. Rosters can include the whole team or subsets of teams (e.g.,offense, defense, JV, freshman, etc.). To create a roster, the user willselect the “Roster List” tab. In keeping with the previous example, theuser selects “+” button appearing on the window generated as a result ofthe selection of the “Roster List” tab to create a new roster. Then, asshown in UI 2000F, using the check box to the left of the player ID, theuser selects the player the user wishes to have in the roster and savethe changes. In one implementation, only the players with an assignedplayer helmet and position will be listed among the list of drop downmenu.

FIG. 8G illustrates an exemplary UI 2000G allowing the user to assignthe roster to an alert unit 1120. After creating the roster, the usershould assign it to the alert unit. To do so, the user may go to“Equipment Assignments” tab and select “Alert Monitor” tab within thewindow generated by selection of “Equipment Assignments” tab. Then, theuser may click on the alert monitor option and the roster list that itbe paired to. As shown, in UI 2000G, alert unit “mon 1” is paired with“roster 1.” The user may then click “Save Changes” button. Additionally,the user can change the alert type for this alert unit using the dropdown box on the right of UI 2000G. Next, to communication thisinformation to the player helmet, the user should synchronize. The “SYNCREQUIRED” tab in the top right will change color to indicate that a syncis required.

FIG. 8H illustrates an exemplary UI 2000H allowing the user to identifythe in-helmet unit(s) 1200 that require a sync and the process forsyncing same. To learn which in-helmet unit 1200 among the manyconfigured units 1200 require a sync, the user can hover cursor over the“SYNC REQUIRED” tab on the UI 2000H. If one or more in-helmet units 1200require a sync, these in-helmet units 1200 will appear in the drop downlist. The user can then select the necessary in-helmet units 1200 in thelist to start the synchronization wizard. The UI 2000H may alert theuser to ensure that there is an alert unit 1120 connected to the PCterminal 1130 before selecting a sync for the identified in-helmet unit1200. Next, the user is instructed to hold the round sync button for theselected player helmet 1110 for prolonged period of time (e.g., 5seconds). Once the orange light starts to blink, the selected playerhelmet 1110 is synced with the in-helmet unit 1200. The user can thencontinue with the wizard instructions noted above until all of theidentified in-helmet units 1200 are synced.

FIG. 81 illustrates an exemplary UI 20001 allowing the user to identifythe alert units 1120 that require a sync and to sync the identifiedalert units 1120. To complete the sync required for alert units 1120,the user can hover cursor over the “SYNC REQUIRED” tab on the UI 20001.If one or more alert units 1120 require a sync, alert units 1120 willappear in the drop down menu. The user can then select one of theidentified alert units 1120 while the alert unit 1120 is connected tothe user terminal 1130 to sync the alert unit 1120. Once the “SYNCREQUIRED” image is grayed out, the sync is completed and the user isready to use the system 1100.

FIG. 9 illustrates an exemplary UI 2100 allowing the user to downloadalerts. To download alerts, the user opens PMS application and connectsthe alert unit 1120 to the computer. The PMS application will thenautomatically check the alert unit 1120 for new alerts and downloads anddisplays them to the “ALERT MANAGEMENT” tab. New alerts may be shown asbold and checked. Bolded alerts are considered “Unread” alerts.Selecting them will un-bold the text. Also, selecting “Mark As Read”button will un-bold all check alerts. Selecting the “Delete” button willremove all checked alerts from the list. To save alerts, user can exportthe data to the excel by selecting “Export to Excel” button on UI 2100.Selecting “Export to Excel” creates a comma delimited file of allchecked alerts. The columns in the file correspond with the columns inthe software.

FIG. 10 illustrates an exemplary UI 2200 allowing the user to modifysystem settings. To do so, the user selects “SYSTEM SETTINGS” on the UI2200, which results in display of “default settings” icon and “data”icon. The “default settings” icon allows the user to set the defaultskill level for newly created player. The “data” icon allows the userfor backing up of the database. This can be used for general disasterrecovery or to switch computers and keep the data. The bottom section ofUI 2200 allows for updating of firmware for both in-helmet units 1200and alert units 1120.

FIG. 11 illustrates an exemplary alert unit 1120. The alert unit 1120 isconfigured to display three types of alert signals: sound, visual (e.g.,blinking light on alert unit), and vibration. The alert signal isreceived when the alert unit 1120 is within 50 yards of the in-helmetunit 1200. The alert signal is stored within the control module 1230 ofthe in-helmet unit 1200 until the alert unit 1120 is within range. Oncethe alert unit 1120 is turned ON, it will display a standard menu. Themenu includes “Alerts,” “Check-ins,” and “Settings” options. Theselection of the “Alerts” option allows the user to view the existingalerts for various players. The alerts may identify the name of theplayer and the date the alert was generated. The user can select analert specific to a player by clicking on the name of the specificplayer. The user can then see the type of alert (e.g., single impact orcumulative impact) for the specific player. The selection of “Check-in”options allows the user to check-in players that are present today amongthe players in the roster. Selecting this option allows the user to alsoview players who are absent today among the players in the roster. Theselection of “settings” allows the user to set the date and time in thealert unit 1120.

This disclosure may also include a method of evaluating and treatingplayers that experience an Alert Event. A signaling device may beprogrammed with interactive software (e.g., interactive softwareprograms, signaling device software, interactive wizards, interactivewizard programs, wizard software, wizard programs, wizard softwareprograms, wizard software package) that assures best practices arefollowed in the treatment and documentation of injuries, such as mildtraumatic brain injuries (MTBI). The interactive software may include abundle of team management programs which enables the signaling device tostore all team data, including medical histories and testing baselines.The interactive software also provides the signaling device with anactive response protocol for guiding sideline personnel throughappropriate examination procedures and recording the results. Forexample, when an Alert Event occurs and the relevant player is broughtto the sideline for evaluation, the signaling device can display theindividual's head-injury history, the results of previous evaluationsand other pertinent medical data. With the assistance of the interactivesoftware, the signaling device prompts the medical staff member toconduct the appropriate sideline examination, records the responses,compares the results to established baselines and prompts either furthertesting or a play/no-play decision. The interactive software furtherincludes a bundle of team management tools that includes a rosterprogram which contains all the basic information about each individualplayer: e.g., contact information, which sports they play (includingposition and jersey number), emergency information, relevant sizes,equipment issues and availability to play. Information can be stored andsorted in a variety of ways, such as by team, person item and size. Theinteractive software may also include a session manager program thatallows the coaching staff to document incidents as they occur during apractice or a game. The appropriate information about the team, playersand conditions is entered at the beginning of each session. Then, asinjuries occur, the interactive software provides a template forrecording injury data on a per player basis. The data and results storedon the device can be uploaded to the database wherein authorized userscan access same for team management and player evaluation functions.

The database 1150 may be configured to store and provide access toparameter data measured by the in-helmet unit (or monitoring unit) 1200and calculated data from any of the control module 1230, the alert unit1120, and the user terminal 1130. For example, the database 1150 servesas a team administrator database for the athletic department of acollege or university, wherein the database 1150 functions as aninteractive clearinghouse or warehouse for all athlete informationshared among various departments or sports. The database 1150 allows theuser to create players and assign player units to players, to reviewhistorical alerts and to update new firmware on both alert monitors andplayer units. No internet connection is required except to download newfirmware and/or software. The database 1150 may be internet enabled toprovide remote access to authorized users, including coaches, trainers,equipment managers and administrators, which allows the users to keepabreast of changes in players' status. The database 1150 also provides ahost of administrative and management tools for the team andadministrative staff. The database 1150 can be a component of thecollege's broader computer network system and interact with otherdatabases associated with the system 1100. On a smaller level, such asthat found in high schools, the database 1150 can be located on the userterminal 1130, wherein personnel associated with the high school haveaccess, either direct or remote.

As known in the data processing and communications arts, ageneral-purpose computer typically comprises a central processor orother processing device, an internal communication bus, various types ofmemory or storage media (RAM, ROM, EEPROM, cache memory, disk drivesetc.) for code and data storage, and one or more network interface cardsor ports for communication purposes. The software functionalitiesinvolve programming, including executable code as well as associatedstored data. The software code is executable by the general-purposecomputer that functions as the user terminal 1130. In operation, thecode is stored within the general-purpose computer platform. At othertimes, however, the software may be stored at other locations and/ortransported for loading into the appropriate general-purpose computersystem.

FIGS. 12 and 13 provide functional block diagram illustrations ofgeneral purpose computer hardware platforms. FIG. 12 illustrates anetwork or host computer platform, as may typically be used to implementa server. FIG. 13 depicts a computer with user interface elements, asmay be used to implement a personal computer or other type of workstation or terminal device, although the computer of FIG. 13 may alsoact as a server if appropriately programmed. It is believed that thoseskilled in the art are familiar with the structure, programming andgeneral operation of such computer equipment and as a result thedrawings should be self-explanatory.

A server, for example, includes a data communication interface forpacket data communication. The server also includes a central processingunit (CPU), in the form of one or more processors, for executing programinstructions. The server platform typically includes an internalcommunication bus, program storage and data storage for various datafiles to be processed and/or communicated by the server, although theserver often receives programming and data via network communications.The hardware elements, operating systems and programming languages ofsuch servers are conventional in nature, and it is presumed that thoseskilled in the art are adequately familiar therewith. The serverfunctions may be implemented in a distributed fashion on a number ofsimilar platforms, to distribute the processing load.

Hence, aspects of the methods for operating the system 1100 outlinedabove may be embodied in programming. Program aspects of the technologymay be thought of as “products” or “articles of manufacture” typicallyin the form of executable code and/or associated data that is carried onor embodied in a type of machine readable medium. “Storage” type mediainclude any or all of the tangible memory of the computers, processorsor the like, or associated modules thereof, such as varioussemiconductor memories, tape drives, disk drives and the like, which mayprovide non-transitory storage at any time for the software programming.All or portions of the software may at times be communicated through theInternet or various other telecommunication networks. Thus, another typeof media that may bear the software elements includes optical,electrical and electromagnetic waves, such as used across physicalinterfaces between local devices, through wired and optical landlinenetworks and over various air-links. The physical elements that carrysuch waves, such as wired or wireless links, optical links or the like,also may be considered as media bearing the software. As used herein,unless restricted to non-transitory, tangible “storage” media, termssuch as computer or machine “readable medium” refer to any medium thatparticipates in providing instructions to a processor for execution.

Hence, a machine readable medium may take many forms, including but notlimited to, a tangible storage medium, a carrier wave medium or physicaltransmission medium. Non-volatile storage media include, for example,optical or magnetic disks, such as any of the storage devices in anycomputer(s) or the like, such as may be used to implement the methodsfor enabling operation of system 1100. Volatile storage media includedynamic memory, such as main memory of such a computer platform.Tangible transmission media include coaxial cables; copper wire andfiber optics, including the wires that comprise a bus within a computersystem. Carrier-wave transmission media can take the form of electric orelectromagnetic signals, or acoustic or light waves such as thosegenerated during radio frequency (RF) and infrared (IR) datacommunications. Common forms of computer-readable media thereforeinclude for example: a floppy disk, a flexible disk, hard disk, magnetictape, any other magnetic medium, a CD-ROM, DVD or DVD-ROM, any otheroptical medium, punch cards, paper tape, any other physical storagemedium with patterns of holes, a RAM, a PROM and EPROM, a FLASH-EPROM,any other memory chip or cartridge, a carrier wave transporting data orinstructions, cables or links transporting such a carrier wave, or anyother medium from which a computer can read programming code and/ordata. Many of these forms of computer readable media may be involved incarrying one or more sequences of one or more instructions to aprocessor for execution.

While the foregoing has described what are considered to be the bestmode and/or other examples, it is understood that various modificationsmay be made therein and that the subject matter disclosed herein may beimplemented in various forms and examples, and that the teachings may beapplied in numerous applications, only some of which have been describedherein. It is intended by the following claims to claim any and allapplications, modifications and variations that fall within the truescope of the present teachings.

For example, the system 1100 may be equipped with an automatic on/offsystem that detects the system is in use. This feature prevents thepotential of false alarms due to handling helmet outside the field useand provides extended battery life (1+ season of use without a batterychange). The system 1100 is an Omni-Directional device. To this end, thesystem 1100 has five distinct channels. The distinction of channelsenables the calculation of not only the severity of the impact, but alsothe location of impact. This location estimate is an important componentof the HITsp calculation. The impact location factor increases thesensitivity of the over-exposure threshold to providing direction on thepossibility of concussion.

In another implementation, the shake sensor is used for pairing, powerup, power down. The shake sensor is a motion sensor. The system will goto sleep if there is no motion.

In another implementation, as noted above, when a single or multipleimpact exceeds the threshold (either a single threshold or cumulativethreshold), an alert is wirelessly transmitted from the in-helmet units1200 to the alert unit 1120. The transmission from the in-helmet units1200 to the alert unit 1120 may be encoded with the player's uniqueidentifier.

In one implementation, the alert unit provides acknowledgment of thealert unit to the player helmet. The player helmet may not check-in withalert unit during the course of play, and the alert unit does not querythe player helmet during the course of play. However, the player helmetmay check with the alert unit once every day independent of alert. Thisallows the player helmet to update time and provides a basic check ofsystem function by the user with the alert unit. Update time is to synctimes between player helmet and alert unit. Alert times are thereforerelative to alert unit times, which is realistically actual time. Thealert unit gets updated from the computer every time it is connected,which keeps time drift very low. Also, time accuracy is maintained onthe alert unit when not connected to a PC by using an onboard real-timeclock.

In another implementation, the system can identify and report impropertackling technique, i.e., spearing (head first) tackling. To this end,the system may record impact frequency by magnitude and location andreport that information back to the user.

Other implementations are contemplated.

The invention claimed is:
 1. A system for monitoring of at least one physiological parameter of a body part of a specific player in a subset of multiple players from a larger group of players engaged in play of a contact sport, the system comprising: a plurality of monitoring units, each individual monitoring unit configured to be worn by one of the specific players in the subset of multiple players, the monitoring unit having both a sensor assembly and a control module, said monitoring unit is configured to actively monitor at least one physiological parameter of the body part of the specific player while engaged in play of the contact sport, wherein the monitoring unit is further configured to determine a single incidence physiological parameter value and a cumulative incidence physiological parameter value, wherein the incidence physiological parameter value is determined by the control module from a single measurement of the at least one physiological parameter of the body part of the specific player by the sensor assembly, and wherein the single incidence physiological parameter value is compared to a first predetermined threshold that is based upon the single incidence physiological parameter value; and wherein the cumulative incidence physiological parameter value is determined by the control module from an accumulation of single incidence physiological parameter values that exceed a second predetermined threshold while the player is engaged in playing the contact sport over an extended period of time; wherein the monitoring unit is configured to generate a first alert when the single incidence physiological parameter value exceeds the first predetermined threshold, and to generate a second alert when the cumulative incidence physiological parameter value exceeds a third predetermined threshold that is based upon accumulation of the single incidence physiological parameter values; and a portable alert unit configured to receive any of the first alert and second alert transmitted from a specific monitoring unit that has generated the first alert or the second alert, and wherein the portable alert unit is configured to display information relating to both the received first alert or second alert, wherein the first and second alerts include information to identify the specific player associated with the received first alert or second alert.
 2. The monitoring system of claim 1 wherein the sensor assembly comprises a plurality of sensors formed from an electret film.
 3. The monitoring system of claim 1 further comprising a protective sports helmet configured to be worn by the specific player, wherein the sports helmet includes (i) an internal padding assembly and (ii) overliner, wherein the sensor assembly is configured to be positioned within the overliner, wherein the overliner is further configured to be positioned between the specific player's head and the internal padding assembly when the sports helmet is worn by the specific player.
 4. The monitoring system of claim 3 wherein the sensor assembly further comprises a front sensor positioned adjacent a front region of the sports helmet, a rear sensor positioned adjacent a rear region of the sports helmet, a left sensor positioned adjacent a left region of the sports helmet, a right sensor positioned adjacent a right region of the sports helmet and a top sensor positioned adjacent a top region of the sports helmet.
 5. The monitoring system of claim 1, wherein the at least one physiological parameter actively monitored by the monitoring unit is a pressure measurement resulting from an impact to a helmet adapted to be worn by the specific player during play of the contact sport.
 6. The monitoring system of claim 1 wherein both the first predetermined threshold and the second predetermined threshold are weighted to account for the specific player's skill level.
 7. The monitoring system of claim 1 wherein both the first predetermined threshold and the second predetermined threshold are weighted to account for the specific player's position.
 8. The monitoring system of claim 1 wherein the monitoring unit includes an accumulator configured to determine the cumulative incidence physiological parameter value, and wherein the accumulator is further configured to decrease the cumulative incidence physiological parameter value based on an exponential decay function.
 9. The monitoring system of claim 1 wherein the portable alert unit is further configured to associate each monitoring unit with each specific player in the subset of multiple players, wherein the portable alert unit is configured to (i) connect to each monitoring unit and (ii) transmit information associated with each specific player to each monitoring unit that is associated with that specific player.
 10. The monitoring system of claim 9 further comprising a remote user terminal that is configured to: (i) receive information that is associated with each of the specific players in the subset of multiple players, (ii) connect to the portable alert unit, and (iii) transmit to the portable alert unit the received information that is associated with each of the specific player in the subset of multiple players.
 11. The monitoring system of claim 10 further comprising a database that is configured to store the first and the second alerts generated by the monitoring units and transmitted to the portable alert unit.
 12. The monitoring system of claim 6 wherein (i) the weighted first predetermined threshold is set to the 99^(th) percentile for the specific player's skill level, and (ii) the weighted second predetermined threshold is set to the 95^(th) percentile for the specific player's skill level.
 13. The monitoring system of claim 7 wherein (i) the weighted first predetermined threshold is set to the 99^(th) percentile for the specific player's position, and (ii) the weighted second predetermined threshold is set to the 95^(th) percentile for the specific player's position.
 14. A system for monitoring a physiological parameter of a head of a player engaged in play of a contact sport, the system comprising: a protective sports helmet configured to be worn by the player engaged in playing the contact sport; a monitoring unit positioned within the sports helmet and associated with the player, the monitoring unit having both a sensor assembly and a control module, said monitoring unit is configured to monitor a physiological parameter of the head of the player, the monitoring unit configured to determine a single incidence physiological parameter value from a measurement by the sensor assembly; wherein the single incidence physiological parameter value is compared, by the control module, to a first predetermined threshold to determine when the single incidence physiological parameter value exceeds the first predetermined threshold; wherein the single incidence physiological parameter value is further compared, by the control module, to a second predetermined threshold to determine when the single incidence physiological parameter value should be included in the determination of a cumulative incidence physiological parameter value; wherein a cumulative incidence physiological parameter value is calculated, by the control module, from an accumulation of single incidence physiological parameter values that exceed the second predetermined threshold; wherein the cumulative incidence physiological parameter value is compared, by the control module, to a third predetermined threshold to determine when the cumulative incidence physiological parameter value exceeds the third predetermined threshold; and wherein the monitoring unit is configured to generate a first alert when the single incidence physiological parameter value exceeds the first predetermined threshold and to generate a second alert when the cumulative incidence physiological parameter value exceeds the third predetermined threshold, and wherein the first and second alerts include information to identify a specific player associated with the alerts.
 15. The monitoring system of claim 14 further comprising a portable alert unit configured to receive any of the first alert and second alert transmitted from the monitoring unit and being further configured to display information relating to the received first alert or second alert and an identification of the specific player associated with the received first alert or second alert.
 16. The monitoring system of claim 14, wherein the sports helmet includes an internal padding assembly and an overliner that is configured to be positioned between the player's head and the internal padding assembly when the sports helmet is worn by the player, and wherein the sensor assembly resides within the overliner.
 17. The monitoring system of claim 14 wherein at least one of the first predetermined threshold and the second predetermined threshold is weighted to account for the player's position.
 18. The monitoring system of claim 14 wherein the monitoring unit includes an accumulator configured to determine the cumulative incidence physiological parameter value, and wherein monitoring unit is further configured to decrease the cumulative incidence physiological parameter value based on an exponential decay function.
 19. The monitoring system of claim 14 wherein the control module is configured to determine an alert is not to be generated a first time the single incidence physiological parameter value exceeds the second predetermined threshold and is less than the first predetermined threshold.
 20. A system for monitoring a physiological parameter of a body part of a player engaged in play of a contact sport, the system comprising: a protective sports equipment configured to be worn adjacent to the players body part while the player is engaged in playing the contact sport; a monitoring unit positioned within the sports equipment and associated with the player, the monitoring unit having both a sensor assembly and a control module, said monitoring unit is configured to monitor a physiological parameter of the body part of the player, the monitoring unit configured to determine a single incidence physiological parameter value from a measurement by the sensor assembly; wherein the single incidence physiological parameter value is compared, by the monitoring unit, to a first predetermined threshold to determine when the single incidence physiological parameter value exceeds the first predetermined threshold; wherein the single incidence physiological parameter value is further compared, by the monitoring unit, to a second predetermined threshold to determine when the single incidence physiological parameter value should be included in the determination of a cumulative incidence physiological parameter value; wherein a cumulative incidence physiological parameter value is calculated, by the monitoring unit, from an accumulation of single incidence physiological parameter values that exceed the second predetermined threshold; wherein the cumulative incidence physiological parameter value is compared, by the monitoring unit, to a third predetermined threshold to determine when the cumulative incidence physiological parameter value exceeds the third predetermined threshold; wherein the monitoring unit is configured to generate a first alert when the single incidence physiological parameter value exceeds the first predetermined threshold and to generate a second alert when the cumulative incidence physiological parameter value exceeds the third predetermined threshold, and wherein the first and second alerts include information to identify a specific player associated with the alerts.
 21. The monitoring system of claim 20 wherein the monitoring unit is associated with the player by weighting the second predetermined threshold to account for the player's skill level and the player's position.
 22. The monitoring system of claim 21 wherein cumulative incidence physiological parameter value is decreased based on an exponential decay function.
 23. The monitoring system of claim 20 wherein the protective sports equipment is a football helmet.
 24. The monitoring system of claim 20 wherein the protective sports equipment is a shoulder pad.
 25. The monitoring system of claim 20 further comprising a portable alert unit that is (i) worn by a separate individual not engaged in playing the sport, (ii) configured to receive any of the first alert and second alert transmitted from the monitoring unit, and (iii) configured to display information relating to the received first alert or second alert and an identification of the specific player associated with the received first alert or second alert. 